U.S. patent application number 10/472972 was filed with the patent office on 2004-06-17 for needle-suture combinations and methods of use.
Invention is credited to Lattouf, Omar M.
Application Number | 20040116963 10/472972 |
Document ID | / |
Family ID | 27663054 |
Filed Date | 2004-06-17 |
United States Patent
Application |
20040116963 |
Kind Code |
A1 |
Lattouf, Omar M |
June 17, 2004 |
Needle-suture combinations and methods of use
Abstract
Needle-suture combinations are disclosed that include two
surgical needles, each including an end having a suture-receiving
aperture, and two sutures attached to the ends of each of the two
needles. Also disclosed are methods for using the needle-suture
combination, the method including passing through a first tissue
and a second tissue two needle-suture combinations each having
first and second needles connected to first and second sutures;
pulling the sutures therethrough; disconnecting the needles from
the sutures, thereby providing free ends on the sutures; tying the
free ends of the first sutures of the first needle-suture
combination together; and tying the free end of the second suture
of the first needle-suture combination with the second suture of
the second needle-suture combination. With the apparatus and/or
method, elements joined together may form a more hemostatic
seal.
Inventors: |
Lattouf, Omar M; (Atlanta,
GA) |
Correspondence
Address: |
Christopher B Linder
Thomas Kayden Horstemeyer & Risley
Suite 1750
100 Galleria Parkway NW
Atlanta
GA
30339-5948
US
|
Family ID: |
27663054 |
Appl. No.: |
10/472972 |
Filed: |
September 26, 2003 |
PCT Filed: |
January 24, 2003 |
PCT NO: |
PCT/US03/02367 |
Current U.S.
Class: |
606/224 |
Current CPC
Class: |
A61B 2017/0608 20130101;
A61B 2017/00243 20130101; A61B 17/0401 20130101; A61B 17/06
20130101; A61B 2017/0458 20130101; A61B 2017/00783 20130101; A61B
2017/0414 20130101; A61B 2017/0464 20130101; A61B 17/00234
20130101; A61B 2017/0406 20130101; A61B 17/0469 20130101; A61B
2017/06057 20130101 |
Class at
Publication: |
606/224 |
International
Class: |
A61B 017/06 |
Foreign Application Data
Date |
Code |
Application Number |
Jan 26, 2002 |
US |
60352184 |
Claims
Therefore, having thus described the invention, at least the
following is claimed:
1. A needle-suture combination comprising: two surgical needles,
each including an end having a pointed tip and an end having a
suture-receiving aperture; and a first suture and a second suture
attached to each of the two needles at the end having a
suture-receiving aperture.
2. The needle-suture combination of claim 1, wherein the
suture-receiving aperture end of the needle is swaged on both the
first and second sutures.
3. The needle-suture combination of claim 1, wherein the first and
second sutures are intertwined into a single fiber at each end,
forming a single end portion, and wherein the suture-receiving
aperture end of the needle is swaged on the single end portion of
the intertwined sutures.
4. The needle-suture combination of claim 1, wherein the first and
second sutures are attached to the suture-receiving aperture end of
the needle via at least one of the following: glue, cement,
adhesive, ultrasonic welding, shrink-wrap tubing and combinations
thereof.
5. The needle-suture combination of claim 1, wherein the first and
second sutures have different colors.
6. A needle-suture combination comprising: two surgical needles,
each including an end having a suture-receiving aperture; a first
suture and a second suture attached to each of the two needles at
the suture-receiving aperture end; and a pledget member, wherein
the first and second sutures are threaded through the pledget.
7. The needle-suture combination of claim 6, wherein the pledget
has a shape chosen from: circular, elliptical, square, rectangular,
tubular and combinations thereof.
8. The needle-suture combination of claim 6, wherein the pledget
further comprises two openings therethrough.
9. The needle-suture combination of claim 8, wherein the first and
second sutures are woven through the two openings.
10. The needle-suture combination of claim 6, wherein the pledget
further comprises a first pair and a second pair of openings
therethrough.
11. The needle-suture combination of claim 10, wherein the first
suture is woven through the first pair of the openings and the
second suture is threaded through the second pair of the
openings.
12. The needle-suture combination of claim 6, wherein the pledget
is substantially fixed along the length of the first and second
sutures.
13. The needle-suture combination of claim 6, wherein the pledget
is slidable along the first and second sutures.
14. The needle-suture combination of claim 6, wherein the pledget
comprises at least two openings, and wherein the first and second
sutures are threaded through the openings and are tied in a knot,
the knot being positioned between the openings.
15. The needle-suture combination of claim 6, wherein the pledget
comprises at least two openings, and wherein the first and second
sutures are woven through the suture mounting openings and are tied
in two knots, each knot being located between the openings.
16. The needle-suture combination of claim 6, wherein the pledget
comprises at least two openings, and wherein the first and second
sutures are threaded through the openings and are tied in at least
three knots, each of the knots being positioned between the
openings.
17. A needle-suture combination comprising: two surgical needles,
each including an end having a pointed tip and an end having a
suture-receiving aperture; a first suture and a second suture
attached to each of the two needles at the end having a
suture-receiving aperture, wherein the first and second sutures
have different colors, and wherein the suture-receiving aperture
end of the needle is swaged on both the first and second sutures;
and a pledget member, wherein the first and second sutures are
threaded through the pledget, wherein the pledget further comprises
a first pair and a second pair of openings therethrough, and
wherein the first suture is woven through the first pair of the
openings and the second suture is threaded through the second pair
of the openings and are tied in a knot, the knot being positioned
between the openings.
18. A method of using a needle-suture combination, comprising:
passing through a first tissue and a second tissue two
needle-suture combinations each having first and second needles
connected to first and second sutures; pulling the sutures
therethrough; disconnecting the needles from the sutures, thereby
providing free ends on the sutures; tying the free ends of the
first sutures of the first needle-suture combination together; and
tying the free end of the second suture of the first needle-suture
combination with the second suture of the second needle-suture
combination.
19. The method of claim 18, further comprising forming a
fluid-tight seal between the first tissue and the second
tissue.
20. The method of claim 18, wherein the method is used to
accomplish at least one of the following: heart valve replacement,
aortic anastomosis, vascular grafting, ventricular wall
aneurysectomy, coronary revascularization, bowel anastomosis and
suturing of other circular incisions.
21. The method of claim 18, further comprising contacting the first
tissue with pledgets fixed on the sutures.
22. The method of claim 21, further comprising providing counter
tension with a knot in the sutures disposed between openings in the
pledget.
Description
CLAIM OF PRIORITY
[0001] This application claims priority to copending U.S.
provisional application entitled, "Double stitch: A new
suture-needle combination with two surgical needles attached
together by two strings of sutures instead of one. Prepared with or
without pledget," having Ser. No. 60/352,184 filed Jan. 26, 2002,
which is entirely incorporated herein by reference.
BACKGROUND
[0002] 1. Field of the Invention
[0003] The present invention is generally related to surgical
needles and sutures and, more particularly, is related to
needle-suture combinations and methods for using needle-suture
combinations.
[0004] 2. Description of Related Art
[0005] For many years, surgeons have employed needle-suture
combinations in which a suture or ligature is attached to the shank
end of a needle. An exemplary prior art needle-suture combination
is depicted in FIGS. 1A and 1B. The needle-suture combination 10
illustrated in FIG. 1A includes a pair of needles 12 mounted to the
ends 13 of the suture 14. A pledget member 16 is mounted to a
center portion 17 of the suture 14. The pledget 16 has a top side
18, sides 19 and a bottom side 21. The suture 14 extends or is
"woven" through the pledget 16 through suture mounting holes 23, as
can be seen more clearly in FIG. 1B. Because the suture 14 attached
to each needle 12 is a single suture, one disadvantage is that the
suture 14 may not be strong enough in certain applications, or the
suture 14 may need to be made of a particularly strong material.
Further, patients undergoing anastomosis and heart valve
replacement procedures performed using the needle-suture
combination 10 may experience leaking of blood and fluid through
the stitches formed, particular under high aortic pressures.
Problems associated with this complication are detailed below.
[0006] An alternative exemplary prior art needle-suture combination
is depicted in FIG. 2, and is manufactured by and commercially
available from Genzyme Surgical Products Corp., Fall River, Mass.,
USA, under the name NextStitch.TM.. The needle-suture combination
25 includes ten needles 27 mounted to and connecting the ends 28 of
the nine sutures 29, in the configuration shown in FIG. 2. The
needles 27 on the two ends of the needle-suture combination 25 are
each mounted to one suture 29, while the needles 27 in the middle
of the needle-suture combination 25 are each mounted to the two
sutures 29. As with the needle-suture combination 10 of FIGS. 1A
and 1B, the pledget members 35 are mounted to a center portion of
the sutures 29. The pledgets 35 are generally of the configuration
of the pledget 16 of FIGS. 1A and 1B. Again, similar to FIGS. 1A
and 1B, sutures 29 extend or are "woven" through each respective
pledget 35 through suture mounting holes (not shown).
[0007] The needle-suture combination 25 is designed for use
primarily as a cardiovascular valve suture. While the needle-suture
combination 25 was designed in attempt to solve some of the
problems and disadvantages presented by the needle-suture
combination 10, other problems and disadvantages are associated
with its use. The needle-suture combination 25 is conventionally
sold in a needle-suture pack in the configuration illustrated in
FIG. 2, i.e., ten needles 27 mounted to nine sutures 29 and nine
pledgets 35 mounted on the sutures 29. Therefore, if the desired
application calls for fewer than nine stitches, or a number of
stitches not a multiple of nine, the extra needles and sutures have
to be cut off the needle-suture combination 25. Unfortunately, the
needle-suture combination 25 can be difficult or confusing to
implement in surgery. In using the needle-suture combination 25, a
new procedure is involved in the interaction between a surgeon and
an assistant or nurse aiding the surgeon. To keep the needles and
sutures in order, a large amount of training and practice must be
completed before the needle-suture combination 25 can be used.
Further, if the needles and sutures get tangled, or out of order,
after being threaded through a patient's flesh, they must all be
cut out and the surgeon must begin again, wasting operating time
and possibly damaging the patient tissue.
[0008] Needle-suture combinations, such as those depicted in FIGS.
1A, 1B, and 2 are used in a variety of surgical procedures and, in
particular, with vascular surgery. Important types of vascular
surgery include replacement or bypassing of a diseased, occluded,
or injured artery and heart valve replacement surgery. Arterial
replacement or bypass grafting has been performed for many years
using open surgical techniques and a variety of prosthetic grafts.
These grafts are manufactured as fabrics (often from DACRON.RTM.
(polyester fibers) or TEFLON.RTM. (fluorocarbon fibers)), or are
prepared as autografts (from the patient's own tissues) or
heterografts (from the tissues of animals) or a combination of
tissues, semi-synthetic tissues and/or alloplastic materials. A
graft can be joined to the target artery in a number of different
positions, including end-to-end, end-to-side, and side-to-side.
This attachment between artery and graft, or any two vessels, is
known as an "anastomosis."
[0009] The replacement of diseased or damaged heart valves with
artificial heart valves is also a relatively common surgical
procedure. The replacement of a heart valve is necessary when the
native valve becomes sufficiently incompetent such that coronary
function is compromised. There are numerous types of conventional
artificial heart valves which can be used in such procedures
including synthetic mechanical, porcine tissue, cryogenically
preserved homografts, and autologous valves from a different
position in the patient's own heart.
[0010] For a valve replacement surgical procedure to be successful,
the junction of the replacement valve and the heart tissue must be
hemostatic, i.e., leakage around the sewing ring must not occur.
Leakage from an inadequately mounted replacement valve, known as
"paravalvular leakage" can result in regurgitation or backflow of
blood that could compromise coronary function. Indeed, paravalvular
leakage after aortic or mitral valve replacement can be a
potentially life-threatening complication. Moderate to severe
paravalvular leakage found after weaning from cardiopulmonary
bypass is usually a result of technical error (i.e., the stitch
pulling through the heart tissue or poor seating or sizing of the
heart valve) and necessitates valve removal and repeat replacement.
Accordingly, in addition to using a sufficient number of sutures,
the sutures must be sufficiently tensioned to prevent leakage. Due
to the relatively narrow diameter of the sutures, tensioning can
cause a number of complications including suture tearing through
tissue, or tissue bunching that inhibits correct seating of the
valve on the annulus. In order to distribute the force applied on
cardiac tissue by the tensioned suture, it is known to mount
various types of buttress materials to suture. One type of
conventional buttress is the pledget described above. The pledget
is mounted to the suture and assists in preventing tissue tear
through.
[0011] Continuous, interrupted, or semi-continuous suture
techniques have been used to place prosthetic valves for valvular
heart disease and are commonly known in the art. The continuous
technique has the advantage of tying fewer knots and therefore
reduces aortic cross clamp time. The major disadvantage of the
continuous technique is the catastrophic complication of prosthetic
valve dehiscence in the event of breakage of a single suture. The
advantages of the interrupted method include security with multiple
sutures anchoring the prosthesis and the everting nature of the
suture. The placement of multiple sutures and multiple ties,
however, prolongs aortic cross clamp time. The semi-continuous or
"hoist" method known in the art combines advantages of both the
interrupted and continuous techniques, but has the disadvantage in
that a breakage in that a breakage in one suture leads to a leak
from the suture line.
[0012] The presence of infection, mismatch between the prosthesis
and heart tissue, excessive tension on sutures or the heart tissue,
and specific technique of suture placement of suture placement or
insufficient of sutures may lead to the occurrence of
periprosthetic leak. Continuous suture techniques have been found
to be associated with a high rate of periprosthetic leak in one
study and found to prevent leak in another.
[0013] Although the surgical sutures and cardiac surgical
procedures of the prior art are adequate for their intended
purpose, there is a need in the art for improved needle-suture
combinations. In particular, there is a need to provide improved,
novel methods of using needle-suture combinations, along with
improved uses for the needle-suture combinations that provide
consistent and improved fluid-tight interfaces between a
replacement heart valve and the tissue in the heart, or between
vessels being anastomosized.
SUMMARY
[0014] Embodiments of the present invention provide surgical
devices, namely needle-suture combinations, and methods for using
the needle-suture combinations.
[0015] Briefly described, one embodiment of such a needle-suture
combination includes two surgical needles, each including an end
having a suture-receiving aperture; and two sutures attached to
each of the two needles at the end having a suture-receiving
aperture.
[0016] One embodiment of a method for using a needle-suture
combination includes: passing through a first tissue and a second
tissue two needle-suture combinations each having first and second
needles connected to first and second sutures; pulling the sutures
therethrough; disconnecting the needles from the sutures, thereby
providing free ends on the sutures; tying the free ends of the
first sutures of the first needle-suture combination together; and
tying the free end of the second suture of the first needle-suture
combination with the second suture of the second needle-suture
combination.
BRIEF DESCRIPTION OF THE DRAWINGS
[0017] Many aspects of the invention can be better understood with
reference to the following drawings. The components in the drawings
are not necessarily to scale. Moreover like reference numerals
designate corresponding parts throughout the several views.
[0018] FIG. 1A is a perspective view of a first prior art
needle-suture combination.
[0019] FIG. 1B is a perspective view of the bottom side of a
pledget shown in FIG. 1 with a suture mounted or woven
therethrough.
[0020] FIG. 2 is a perspective view of a second prior art
needle-suture combination.
[0021] FIG. 3 is a perspective view of an embodiment of the
disclosed needle-suture combination.
[0022] FIG. 4A is a top perspective view illustrating a first
threading arrangement for the pledget shown in FIG. 3.
[0023] FIG. 4B is a bottom perspective view of the threading
arrangement of FIG. 4A.
[0024] FIG. 5A is a top perspective view illustrating a second
threading arrangement of the pledget shown in FIG. 3.
[0025] FIG. 5B is a bottom perspective view of the threading
arrangement of FIG. 5A.
[0026] FIG. 6A is a perspective view of a first knotting
arrangement for a suture woven through a pledget.
[0027] FIG. 6B is a perspective view of a second knotting
arrangement for a suture woven through a pledget.
[0028] FIG. 6C is a perspective view of a third knotting
arrangement for a suture woven through a pledget.
[0029] FIG. 7A is a side view of a first attachment arrangement for
a pair of sutures to a needle.
[0030] FIG. 7B is a side view of a second attachment arrangement
for a pair of sutures to a needle.
[0031] FIG. 8 is a top view illustrating a first application of the
disclosed needle-suture combination.
[0032] FIG. 9 is a side view of FIG. 8 illustrating a first
application of the disclosed needle-suture combination.
[0033] FIG. 10 is a top view illustrating a second application of
the disclosed needle-suture combination.
[0034] FIG. 11 is a line graph comparing a leakage rate of a sample
aortic anastomosis using the disclosed needle-suture combination
with the leakage rate of a sample aortic anastomosis sutured using
a common prior art needle-suture combination.
[0035] FIG. 12 is a bar graph comparing a leakage rate of a sample
aortic anastomosis using the disclosed needle-suture combination
with the leakage rate of a sample aortic anastomosis sutured using
a common prior art needle-suture combination, at a typical
intra-aortic pressure of 10 mmHg.
DETAILED DESCRIPTION
[0036] As identified in the foregoing, needle-suture combinations
and methods for using them are not always sufficient to prevent
leakage between tissues or vessels being stitched together. In
attempting to solve this problem, other needle-suture combinations
may be confusing or difficult to use. Therefore, needed are
needle-suture combinations that provide a more hemostatic seal
between tissues or vessels and that are easy to use.
[0037] Disclosed herein are needle-suture combinations and methods
of using the needle suture combinations. The disclosed
needle-suture combinations provide sutures that allow twice the
number of stitches to be formed using the same number of needle
pulls through the tissues or vessels, forming a more hemostatic
seal between tissues or vessels.
[0038] Referring now to the figures, FIG. 3 illustrates an
exemplary embodiment of a needle-suture combination 100. The
needle-suture combination 100 includes a pair of needles 110
mounted to ends 111 of two sutures 112, 114.
[0039] Needles 110 may be fabricated from metals such as stainless
steel alloys that have desired characteristics with respect to
biocompatibility, strength, and the ability to take a sharp end
and/or point when ground and polished. Generally, the needle can be
fabricated from a material such as series 300 stainless steel
alloy, series 400 stainless steel alloy, or nonferrous alloy, e.g.,
MP35N alloy. Sutures may be of a wide variety of monofilament and
braided suture materials, both absorbable and non-absorbable, e.g.,
catgut, silk, nylon, polyester, polypropylene, linen, cotton, as
well as absorbable synthetic materials such as polymers and
copolymers of glycolic and lactic acids. In most anastomosis and
cardiovascular procedures it is preferable to use a non-absorbable
suture material. In some embodiments the first suture 112 has a
different color than suture 114, so that the two sutures 112, 114
are visually distinct from each other in terms of color or some
other identifying mode. Advantages of having the two sutures being
readily separately identifiable will be described in more detail
below.
[0040] A pledget member 116 may be positioned on a center portion
117 of the sutures 112, 114, with the sutures 112, 114 being
threaded through the pledget 116. The pledget 116 has a top side
119, sides 121, and a bottom side 123 (shown in FIG. 4B). While the
pledget 116 shown throughout the figures is substantially square or
rectangular in shape, other pledget shapes may be used, for
example, circular, elliptical, tubular, and combinations thereof.
The pledget 116 is made from soft, pliable biocompatible materials.
For example, pledget material may include polytetrafluoroethylene
(PTFE), expanded PTFE, polyester, cotton, and combinations
thereof.
[0041] As can be seen more clearly in FIGS. 4A and 4B the sutures
112, 114 may extend, or be "threaded", through the pledget 116
through openings 125 formed by the threading process. In this
configuration, the pledget 116 is slidably mounted to the sutures
112, 114. Alternatively and/or additionally, the pledget 116 may be
fixed in place along the sutures 112, 114 such that it is
stationary.
[0042] While the pledget 116 of FIGS. 3, 4A, and 4B is shown to
have two openings 125, an alternative number of openings 125 may
also be formed. FIGS. 5A and 5B depict an alternative threading
embodiment for the pledget 116. In this embodiment, more than two
openings 125 are formed. In particular, the sutures 112, 114 are
threaded through the pledget 116 so as to form two pairs of
openings 125. With this manner of threading, the first suture 112
may extend through a first pair of openings 125, and the second
suture 114 may extend through a second pair of openings 125.
[0043] In some cases, it may be preferable to have the sutures 112,
114 include a knot 118 on the bottom side 123 of the pledget 116
when they are threaded through the pledget 116, as shown in FIGS.
6A-6C. FIGS. 6A-6C depict alternative configurations for the
placement and number of knots 118. FIG. 6A shows the knot 118
substantially centered between the two openings 125, while FIGS. 6B
and 6C show multiple knots 118. In FIG. 6B there are two knots 118,
with one knot 118 located adjacent each opening 125. FIG. 6C
combines the knot configurations of FIGS. 6A and 6B. Alternative
placement of the knots 118 may be used.
[0044] While FIGS. 6A-C depict knotted sutures 112, 114 threaded
through a single pair of openings 125, the sutures 112, 114 may
also be knotted when mounted to the pledget 116 through multiple
pairs of openings 125. For example, the configurations of knots 118
in FIGS. 6A-6C can also be accomplished when the sutures 112, 114
are threaded through two pairs of openings 125 (as in the
embodiment of FIGS. 5A and 5B). Knot(s) 118 may be advantageous in
that they may prevent the sutures 112, 114 from slipping through
the openings 125 when the sutures 112, 114 are being tied during
surgery. Therefore, knot(s) 118 provide counter-tension on the
sutures 112, 114 when a surgeon is pulling on the sutures 112, 114
in order to tie them tightly, and to press the pledget 116 against
tissue being sutured (as will be described below in more
detail).
[0045] Turning now to FIGS. 7A and 7B, exemplary embodiments are
shown of the attachment of the needle 110 and the sutures 112, 114
of needle-suture combination 100. The sutures 112, 114 may be
attached to the needle 110 in many different manners, including
through use of adhesive such as glue or cement, or by ultrasonic
welding, shrink-wrap tubing, swaging needle 110 over the ends 111
of the sutures 112, 114, and combinations and equivalents thereof.
The needle 110 has two ends, including a pointed tip 127 at one end
and a suture-receiving aperture 129 at the other end. In the
embodiment of FIG. 7A, both suture ends 111 are inserted into the
suture-receiving aperture 129 of the needle 110 and attached by any
of the methods described above. To this end, the suture-receiving
end of needle 110 may be slightly larger than conventional needles,
so as to receive both sutures 112, 114 in the suture-receiving
aperture 129. FIG. 7B illustrates an alternative method of
attachment of the sutures 112, 114 to the needle 110. In FIG. 7B,
the ends 111 of the sutures 112, 114 have been intertwined, or
commingled, forming a single end portion 120. The end portion 120
is then inserted into the suture-receiving aperture 129 and
attached by any method described above to attach a suture to a
needle.
[0046] The needle-suture combination 100 described above is
particularly useful in procedures involving the anastomosization of
vessels and in joining two tissues that are substantially circular
or elliptical in shape. For example, the needle-suture combination
100 may be used in heart valve replacement procedures. FIG. 8
illustrates of a heart tissue X with a replacement valve sutured in
place using an embodiment of the needle-suture combinations 100. In
order to attach a replacement valve in this manner, the surgeon
grasps the needle 110 with a needle grasper and inserts the needle
110 through the heart tissue X and then through a portion of the
replacement valve, such as a sewing ring (not shown). Next, the
surgeon pulls the sutures 112, 114 through the replacement valve
such that the top side 119 of the pledget 116 contacts with the
heart tissue X. The surgeon then places a number of the
needle-suture combinations 100 through the heart tissue X and
replacement valve, spacing the needle-suture combinations 100 a
sufficient distance apart so as to provide effective hemostatic
sealing between the heart tissue X and the replacement valve. This
distance will vary with the condition and age of the patient and
the individual characteristics of the heart tissue X. Typically,
however, this distance is about 1 millimeter (mm) to about 6 mm,
more typically about 2 mm to about 5 mm, and preferably about 3 mm
to about 4 mm. Although not required, it is preferred that every
two adjacent sutures through the heart tissue X and replacement
valve be of the same color.
[0047] Once a sufficient number of needle-sutures 100 have been
threaded through the heart tissue X and the replacement valve, the
surgeon slides or "parachutes" the valve onto the heart tissue X to
place the valve in the position shown in FIG. 8. At that time, the
surgeon cuts the needles 110 from the sutures 112, 114 such that
each suture 112, 114 has a free end 111. The needles 110 are
usually cut from the sutures 112, 114 prior to sliding the valve
into place, but this may also be performed subsequently.
[0048] The surgeon then ties or knots the sutures 112, 114 with
sufficient tension to mount the valve Y to the heart tissue X in a
hemostatic manner, as seen in FIG. 9. Due to the use of the double
sutures 112, 114, the first suture 112 is tied to itself (the
contiguous suture 112 mounted to the pledget 116) to form a first
knot 122. When multiple such knots 122 are tied, a continuous
horizontal "mattress" type suture configuration 127 is obtained, as
shown in FIG. 9. In addition, the second suture 114 is tied to a
different adjacent second suture 114, cut from an adjacent
needle-suture combination 100, forming a second knot 124 and
creating an additional "running" suture configuration 129 along the
ring of valve Y. In situations in which the surgeon uses
needle-suture combinations 100 that include a first suture 112 of a
first color and a second suture 114 of a second color, tying the
knots correctly is simplified. In particular, the surgeon ties
sutures of like colors together. Simplification in tying the knots
helps avoid the situation where the surgeon may have to cut out the
sutures and replace them.
[0049] FIG. 10 illustrates a use of the needle-suture combination
100 in an exemplary anastomosis of two vessels M and N. The ends
111 of adjacent first sutures 112 are tied together, and the ends
111 of the second sutures 114, cut from adjacent needle-suture
combination 100, are tied together, thereby forming a hemostatic
seal around the anastomosized vessels M and N.
[0050] Further, while specific examples of methods of using the
needle-suture combination 100 given above refer to vessel
anastomosis and heart valve replacement procedures, the
needle-suture combination 100 can also be used in many other
procedures, including vascular grafting, ventricular wall
aneurysectomy, coronary revascularization, bowel anastomosis, and
suturing of other circular incisions.
[0051] Testing the Efficacy of Needle-Suture Combination 100
[0052] The efficacy of the needle-suture combination 100, compared
to that of an example prior art needle-suture combination 10 (FIG.
1), is demonstrated through the following procedure.
[0053] Preparation of the Aortic Segment
[0054] Approximately 6 centimeter (cm) segments of the descending
thoracic and upper abdominal aorta was removed from anesthetized
and euthanized canines or swine. The segments were preserved either
in 0.9% sodium chloride for acute usage or 10% formaldehyde for
future testing. The branches of the aortic segments were either
ligated with titanium clips or closed with 4-0 or 5-0 polypropylene
purse-string sutures to ensure no leakage of normal saline when
pressurized manually with a 20 milliliters (mL) syringe. The aortic
segment was then divided in half for plegeted suture
anastomosis.
[0055] Preparation of Needle-Suture Combination 100
[0056] Polytetrafluoroethylene (PTFE), or Teflon.RTM., felt
manufactured by and commercially available from Deknatel, Inc.,
Fall River, Mass. was used and cut into approximately 3 millimeter
(mm) by 5 mm rectangular shapes for use as pledgets. Suture
material used was Tev-Dek..TM., manufactured by and commercially
available from Genzyme Surgical Products Corp. Two 4-0 Tev-Dek.TM.
sutures were passed in and out of the pledget using a french eye
needle.
[0057] Creation and Testing of the Aortic Anastomosis
[0058] The aortic anastomosis was performed using the procedure
described above with respect to FIGS. 8-10, forming a continuous
horizontal "mattress" type suture configuration, as well as a
creating an additional "running" suture configuration. In the test,
two different studies were performed to yield the results shown in
FIGS. 11 and 12. In the first study, two different aortic segments
were anastomosized, first using the needle-suture combination 10 to
form conventional mattress sutures, and second, using the
needle-suture combination 100 to form both mattress sutures and
running sutures, as described above. A leak rate was obtained over
a typical range of intra-aortic pressures in a human (50 to 150
mmHg). In the second study, eight anastomoses were tested at 100
mmHg pressure for leak, using both the method and the needle-suture
combination 100, and using the method and the needle-suture
combination 10 for comparison.
[0059] Results
[0060] The results of the first study are summarized in the line
graph of FIG. 11. The line 126 represents the leak rate over a
range of pressures for aortic anastomosis performed using a method
and the needle-suture combination 10 known in the prior art. The
line 128 represents the leak rate over a range of pressures for
aortic anastomosis performed using an embodiment of the disclosed
method and the needle-suture combination 100. As can be seen from
FIG. 11, the embodiment of the disclosed method, using the
needle-suture combination 100, reduced the leak rate versus the
conventional mattress stitch over a range of pressures (50 to 150
mmHg). The results of the second study are summarized in the bar
graph of FIG. 12. In FIG. 12, the bar 130 represents the leak rate
at 100 mmHg pressure for aortic anastomosis performed using a
mattress stitch technique and the needle-suture combination 10
known in the prior art. The bar 132 represents the leak rate at 100
mmHg pressure for aortic anastomosis performed using the embodiment
of the disclosed method and the needle-suture combination 100. As
can be seen from FIG. 12, the embodiment of the disclosed method,
using the needle-suture combination 100, reduced the leak rate
versus the conventional mattress stitch at 100 mmHg pressure by at
least approximately 17 drops/minute.
[0061] It should be emphasized that the above-described embodiments
of the needle-suture combination and embodiments of method for
using the needle-suture combination are merely possible example
implementations. Many variations and modifications may be made to
the above-described embodiment(s). All such modifications and
variations are intended to be included herein within the scope of
this disclosure and protected by the following claims.
* * * * *